Medical Device Division · registration 140298ActiveRespironics
Hong KongMasks, Air-OxygenClass IIRespironics, Inc.
Official record identity
- MDACS listing number
- 140298
- Model name
- PerforMax Pediatric EE Leak 2 Total Face Mask (1083083, 1083084, 1083147, 1083148), PerforMax Pediatric SE Total Face Mask (1083085, 1083086, 1083149, 1083150)
- Registration date
- August 26, 2024
- Expiry date
- August 25, 2029
- Source update date
- March 06, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class II
Official value: II
Published parties
- Registrant / registration holder
- Philips Electronics Hong Kong Limited
- Manufacturer
- Respironics, Inc.
Official description
Masks, Air-Oxygen
Additional source fields
- AMD nomenclature code
- 12448
- Traditional Chinese local responsible person
- 飛利浦電子香港有限公司
- Local responsible person phone
- 28215888
- Published manufacturer address
- 1001 Murry Ridge Lane, Murrysville, PA 15668, USA.
- Revision number
- d
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.